The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Whole Pth (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model 3kg056.
| Device ID | K001411 |
| 510k Number | K001411 |
| Device Name: | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071 |
| Contact | Richard Lenart |
| Correspondent | Richard Lenart SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-04 |
| Decision Date | 2000-08-21 |